Human Tissue Transplants Safety

by Food and Drug Administration (FDA)

When the surgeon put in a special request for an elbow, Donor Alliance of Denver started searching immediately. The elbow bone and surrounding cartilage had to fit specific dimensions and be from the right arm of a female donor of a certain age. A match was found, and the surgeon transplanted the live joint tissue into 18-year-old Nikki Fix.

Fix had fought leukemia with drugs that saved her life but that had a painful and debilitating side effect. "My joints started to collapse," says the Eaton, Colo., resident, who received her new elbow in September 2004. It wasn't the first such surgery for Fix. The year before, she got a new knee joint from another donor.

"I have a few limitations," says Fix. "I'm not supposed to run or jump, and I have to watch how much I'm lifting." But Fix considers herself fortunate. She is pain-free, has use of her arm again, and walks without limping. And her leukemia has been in remission for two years.

Fix is one of the many people who have benefited from tissue donations. The nation's tissue banks distributed more than 1 million tissue grafts in 2003, according to the American Association of Tissue Banks (AATB). Most tissues come from people who have chosen to donate their organs and tissues after death to help others live longer or to improve their quality of life.

"One donor can save eight lives through organ donation and enhance up to 50 through tissue donation," says Steve Mansfield, vice president of tissue banking operations at Donor Alliance, a nonprofit organization that helps procure organs and tissues, including Fix's elbow and knee.

Organ transplants are usually lifesaving and involve the replacement of whole organs — the kidneys, liver, heart, lungs, pancreas, or intestine. Tissue transplants also are used sometimes to save lives, says Mansfield, but most tissue transplants enhance the lives of recipients. Tissues that can be transplanted include bone, skin, corneas, tendons, ligaments, and heart valves.

Bone tissue can restore function to damaged joints, as in Fix's case. Or it can prevent limb amputation by replacing cancerous bone. A covering of donated skin may prevent infections in severely burned people until new skin can regrow. Donated corneal tissue, the outer coating of the eyeball, can restore sight to people with eye disease. And healthy leg veins can replace damaged arteries in people with poor circulation.

Donated heart-valve tissue can be a lifesaving gift for a person with a failing heart valve. And reproductive tissue, provided by living donors, can be a gift that allows an infertile couple to have children.

But like blood and other body fluids, these living materials can transmit disease. Concern over this potential has led the Food and Drug Administration to strengthen its oversight over the human tissue industry. And the tissue industry and state governments are working with the agency to safeguard patients who receive these life-enhancing and lifesaving tissues.

The Risk

"The overall risk of disease transmission through tissue transplantation is believed to be very low," says Jesse Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. But in the rare incidents of disease transmission, the results have been tragic. In 2001, for example, a 23-year-old Minnesota man died four days after receiving a transplant of bone and cartilage to reconstruct his knee. He had acquired a deadly infection from toxic bacteria in the tissue. A delay in refrigerating the donor cadaver before the tissue was harvested was believed to have triggered the growth of the bacteria, according to the Centers for Disease Control and Prevention (CDC).

In 2002, five tissue recipients in the United States were believed to be infected by hepatitis C from a single donor's tissues. And in 2003, contaminated corneas resulted in infections and vision loss in two people.

Over the years, the development of new processing and surgical techniques has expanded the use of human tissues. Blood stem cells from umbilical cord blood are now used in experimental therapies to treat cancers such as leukemia. And insulin-producing islet cells are now cultured in the laboratory. Researchers hope that injecting islet cells into people with diabetes may one day eliminate the need for pancreas transplants and daily insulin injections, says Ruth Solomon, M.D., acting director of the FDA's Division of Human Tissues.

The expanded use of tissues and the emergence of new infectious diseases bring new safety concerns — and a need for new regulations.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.